Regional Alliance


Regional Alliance of National Regulatory Authorities for Medical Products in the Western Pacific Region
 
Our Vision
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All people in the Western Pacific Region will have access to quality, safe, efficacious medical products.
Mission
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The Regional Alliance will strive to promote and support strategies to strengthen regulatory systems, providing an effective platform for regulatory convergence and cooperation in the Western Pacific Region.

Preamble
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We, the National Regulatory Authorities (NRAs) of the Member States in the Western Pacific Region, duly constitute the Regional Alliance of National Regulatory Authorities in the Western Pacific, and hereby commit to work together and cooperate to strengthen the regulatory systems in this region, thereby ensuring safety, quality and efficacy of medical products, promoting and protecting public welfare and contributing to the attainment of universal health coverage (UHC) and health for all.

 
Regional Alliance for National Regulatory Authorities for Medicines and Vaccines in the Western Pacific Region
Regional Alliance for National Regulatory Authorities for Medicines and Vaccines in the Western Pacific Region
* The number of technical working groups will be identified by the Steering Committee according to the needs of the Member States.


Membership is voluntary and by Member States with duly designated representative who is the head of the National Regulatory Authority or his/her alternate.

History
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In 2011, the Member States of the Western Pacific Region initiated establishment of the Regional Alliance for National Regulatory Authorities (NRAs). It serves as a collaborative platform for Member States to work together in the area of vaccines regulations. Over the years the scope of the alliance has expanded from vaccines to medicines and worked on:


Supporting countries to develop capacity to perform core regulatory functions based on their needs and contexts, guided by the WHO performance criteria for regulatory maturity;



Building capacity for specific regulatory functions including medicines registration, regulatory inspection, quality assurance and pharmacovigilance, quality management systems, laboratory quality assessments, clinical trial oversight and product evaluation;



Partnership and resource mobilization to support resource-limited national regulatory authorities;



A harmonized approach to strengthen the regulation of vaccines and medicines; and



Sharing information, expertise and best practices

Regional Alliance Members
Regional Alliance Members


In 2013, the Regional Alliance constituted the first Steering Committee with representations from the vaccine-producing, self-procuring and UN-procuring countries. The Steering Committee with a term of four years (2013-2017), served as the governing body of the Regional Alliance and was tasked to steer the development of policies and the operationalization of its strategic objectives and workplan.
In 2016, shortly after structural reform to integrate support functions for regulation of medicines and vaccines at WPRO, the Regional Alliance also agreed to expand the scope and transition of WHO Secretariat from the Expanded Programme on Immunization of the Division of Communicable Diseases to the Essential Medicines and Health Technologies of the Division of Health Systems.
In 2017, the Regional Alliance adopted new terms of reference that set out a new mechanism for coordination and governance and modified the selection of the Steering Committee. This time the representation was based on the level of maturity of the regulatory authorities.